EMA selects TrialAssure anonymisation platform for clinical trial documents
pharmafile | July 30, 2026 | News story | |Â Â EMA, TrialAssure, clinical trialsÂ
TrialAssure has announced that its ANONYMIZE platform has been selected by the European Medicines Agency (EMA) for use as an official anonymisation tool to support the publication of clinical trial documents under the Agency’s transparency framework.
The platform will be used to anonymise clinical dossiers submitted by marketing authorisation holders, helping to protect the identity of clinical trial participants before documents are made publicly available in line with EMA Policy 0043.
According to TrialAssure, the selection followed a structured vendor evaluation and market research process conducted by the EMA in 2025 to identify scalable technologies capable of supporting the Agency’s transparency and data protection requirements.
The ANONYMIZE platform combines artificial intelligence-assisted detection with expert review to identify and redact sensitive information while seeking to preserve the scientific value of the underlying clinical data. The technology is designed to support anonymisation across a range of document types, datasets and medical images.
Prasad M. Koppolu, Chief Operating Officer at TrialAssure, said: “Anonymisation should be seen as a core capability that needs to scale, stand up to scrutiny, and support real transparency. It also has to work in real regulatory environments, be auditable, and preserve the value of the data.”
He added that the company’s selection by the EMA recognised the platform’s ability to meet those requirements in a regulatory setting.
The EMA’s adoption of the platform reflects the growing emphasis on balancing clinical trial transparency with patient privacy as regulators continue to expand public access to clinical data.
TrialAssure said it will continue to support pharmaceutical companies, regulatory authorities and research organisations with technologies designed to meet evolving requirements for transparency, compliance and data protection.
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